Drugs developed by the company based in Chengdu High-tech Zone are expected to enter the mainstream European market

On November 26, according to sources from the Biological Industry Development Administration in Chengdu High-tech District, the quality standard of panaxtriol saponins, the bulk pharmaceutical chemicals of developed by Chengdu Taihe Health Technology Group Inc., Ltd. (hereinafter referred to as "Taihe Health") recently has been included in German Pharmacopoeia (the 2018 edition). It is the first time that the standard of traditional Chinese medicine (TCM) extracts with independent intellectual property rights has been included in the pharmacopoeia in the western countries, marking an important step forward in the internationalization of Chinese medicine.


It takes five years to complete the first step

The extraction standard of bulk drug is included in German Pharmacopoeia


Sanqi Tongshu capsule is an original TCM new drug with independent intellectual property rights in China, which came into the market in 2003, and panaxtriol saponins as the bulk drug is an effective preparation extracted from pseudo-ginseng.

"The establishment of international standards for TCM extracts is the foundation for TCM to go global", said Lin Dasheng, Vice President of Taihe Health. It took nearly five years for the company from the early-stage preparations to the inclusion of the standard in the German Pharmacopoeia this month. "The way we adopt is to realize complete registration of new drugs. At first, we have the TCM extracts registered in the European countries, which will lay the foundation for Sanqi Tongshu capsule to enter the mainstream pharmaceutical market in Europe in the future."

Lin further explained that prescription drugs reign the mainstream European market. In order to become prescription drugs calls for the complete registration, and the first step is to have the extraction standard of the bulk drug of the finished drug included in German Pharmacopoeia. Otherwise, the drug can only enter the European market as non-prescription type. As a result, market share will shrink substantially. "Our plan is to introduce Sanqi Tongshu capsule into the mainstream market in Europe as a prescription drug. We have now taken the first step," Lin Dasheng said.

To this end, Taihe Health has developed a complete new drug registration plan. There are two main ways to achieve national registration of TCM products in Europe -- simplified registration route and complete registration of new drugs. According to Lin, the big drawback of simplified registration is that it does not allow access to the European prescription drug market. "If we choose simplified registration, the drug can only enter the European non-prescription market as health supplement." He said the complete registration of new drug will see the drug extract, and the pharmacology, efficacy and safety of the drug verified again and again.

Sanqi Tongshu capsule is expected to enter the European market in 8-10 years

"The first area where TCM influences the world is in the cardiovascular and cerebrovascular diseases. The best proven drug for these diseases is pseudo-ginseng, and we succeeded in eliminating impurities in pseudo-ginseng through exclusive core technology and extracted the effective components for the treatment of cardiovascular and cerebrovascular diseases." It is said that Sanqi Tongshu capsule has been granted China's and European patents. At present, the annual sales revenue of this product is RMB 500 million, and in the future the market revenue is expected to be more than RMB 2 billion.

As it has occupied the domestic market, Taihe Health starts to capture overseas market. "TCM should go global", Lin said. Taihe Health is targeting the European market first for its global strategy.

In 2014, the company set the target to realize the complete registration of new drug in Europe. Over the past five years or so, it had thousands of copies of relevant materials of this medicine extract translated from Chinese into English and then into German. After two scientific consultations in Germany and the Netherlands, the good news finally arrived in November this year. "I was so excited that I didn't sleep all night," Lin said, speaking of his mood at the time.

In his view, this is also a dream for people engaged in TCM. For Taihe Health, the inclusion of Sanqi Tongshu capsule in the German Pharmacopoeia is only the first step in a long march. "Next, we are going to implement the clinical trials of phase I, phase II in Germany, and the time to complete the trials is expected to be 8 to 10 years." Lin said ambitiously: " We prepare to forge a path for the internationalization of TCM."

Reported and Photographed by He Wenwei